Critically IllCITRANSNCT02902276
Link Between Plasma Citrulline and Lipopolysaccharide Concentrations in the Critically Ill
An observational study of Critically Ill, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
In critically ill patients, the small bowel permeability is increased, leading to bacterial translocation, and systemic inflammatory response syndrome. Plasma citrulline is a validated biomarker of functional enterocyte mass. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill
- What is being tested?
- additional blood sample
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2016to Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients requiring ICU admission for at least 48 hours, without chronic small bowel disease, without chronic renal failure (usual clearance of creatinine < 50 mL/min), not pregnant.
Who may be able to join
- Critically ill patients requiring ICU admission for at least 48 hours
- Adults
Who cannot join
- Chronic small bowel disease
- Chronic renal failure (clearance of creatinine < 50 mL/min)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Besançon
Besançon, 25030
Gaël PITON, MD, PhD, 0033381668224, gpiton@chu-besancon.fr
About this study
In critically ill patients, the small bowel permeability is increased, leading to bacterial translocation, and systemic inflammatory response syndrome.
Plasma citrulline is a validated biomarker of functional enterocyte mass. Lipopolysaccharide (LPS) is a part of Gram negative bacteria, and plasma LPS concentration is a biomarker of bacterial translocation. The link between plasma citrulline and LPS in the critically ill is unknown. Investigators hypothesize that patients presenting with low plasma citrulline concentration, with presumed altered small bowel function, would have an increased phenomenon of bacterial translocation, and increased plasma LPS concentration. Investigators aimed to evaluate the link between plasma citrulline and LPS concentrations in critically ill patients at the time of ICU admission.
- Conditions
- Critically Ill
- Being tested
- additional blood sample
- Keywords
- plasma citrulline, lipopolysaccharide, critically ill, Hospitalization in an Intensive Care Unit
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
additional blood sampleOther
Two blood samples will be taken at ICU admission
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma citrulline concentration
biological assay
Measured: Up to 12 hours after admission in the unit
plasma lipopolysaccharide concentration
biological assay
Measured: Up to 12 hours after admission in the unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startJul 2016
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaël Piton, MD, PhD, Principal investigator, CHU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02902276
- Sponsor's protocol ID
- P/2016/187
- Acronym
- CITRANS
- Status last verified
- Sep 2016
- First submitted
- 11 Aug 2016
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Chaignat C, Lagrost L, Moretto K, de Barros JP, Winiszewski H, Grober J, Saas P, Piton G. Plasma citrulline concentration and plasma LPS detection among critically ill patients a prospective observational study. J Crit Care. 2024 Feb;79:154438. doi: 10.1016/j.jcrc.2023.154438. Epub 2023 Oct 3.
PubMed 37797404
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Link Between Plasma Citrulline and Lipopolysaccharide Concentrations in the Critically Ill
- ClinicalTrials.gov ID
- NCT02902276
- Acronym / sponsor ID
- CITRANS / P/2016/187
- Conditions
- Critically Ill
- Keywords
- plasma citrulline, lipopolysaccharide, critically ill, Hospitalization in an Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 15 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In critically ill patients, the small bowel permeability is increased, leading to bacterial translocation, and systemic inflammatory response syndrome.
Plasma citrulline is a validated biomarker of functional enterocyte mass. Lipopolysaccharide (LPS) is a part of Gram negative bacteria, and plasma LPS concentration is a biomarker of bacterial translocation. The link between plasma citrulline and LPS in the critically ill is unknown. Investigators hypothesize that patients presenting with low plasma citrulline concentration, with presumed altered small bowel function, would have an increased phenomenon of bacterial translocation, and increased plasma LPS concentration. Investigators aimed to evaluate the link between plasma citrulline and LPS concentrations in critically ill patients at the time of ICU admission.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients requiring ICU admission for at least 48 hours, without chronic small bowel disease, without chronic renal failure (usual clearance of creatinine < 50 mL/min), not pregnant.
Key inclusion criteria (2 listed)
- Critically ill patients requiring ICU admission for at least 48 hours
- Adults
Key exclusion criteria (3 listed)
- Chronic small bowel disease
- Chronic renal failure (clearance of creatinine < 50 mL/min)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| additional blood sampleTwo blood samples will be taken at ICU admission | Other | – |
Primary outcome
Plasma citrulline concentration
Time frame: Up to 12 hours after admission in the unit
biological assay
plasma lipopolysaccharide concentration
Time frame: Up to 12 hours after admission in the unit
biological assay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
- Derived from this study: PubMed 37797404Chaignat C, Lagrost L, Moretto K, de Barros JP, Winiszewski H, Grober J, Saas P, Piton G. Plasma citrulline concentration and plasma LPS detection among critically ill patients a prospective observational study. J Crit Care. 2024 Feb;79:154438. doi: 10.1016/j.jcrc.2023.154438. Epub 2023 Oct 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaël Piton, MD, PhD principal investigator
CHU Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gaël Piton, MD, PhD (0033381668224, gpiton@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma citrulline concentration (time frame: Up to 12 hours after admission in the unit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02902276, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2016.